A single dose, crossover comparative exposure pharmacokinetic (PK) trial of metoclopramide nasal spray to demonstrate bioequivalence of Gimoti in healthy volunteers
Phase of Trial: Phase I
Latest Information Update: 07 Mar 2018
At a glance
- Drugs Metoclopramide (Primary)
- Indications Diabetic gastroparesis
- Focus Pharmacokinetics; Registrational
- Sponsors Evoke Pharma
- 07 Mar 2018 According to an Evoke Pharma media release, the Company has confirmed the proposed dose for women to be submitted in the NDA, based on the results of this trial.
- 07 Mar 2018 Status changed from active, no longer recruiting to completed, according to an Evoke Pharma media release.
- 15 Feb 2018 According to an Evoke Pharma media release, the company plans to submit its NDA for a female-only indication based on a dose in women with equivalent exposure to Reglan Tablets and will submit supporting efficacy and safety data from this and other trial (see profile 240919) specifically for women, at doses similar or lower than the dose to be proposed in the NDA. The Company expects to file the Gimoti NDA in the second quarter of 2018.